Mount Sinai Hospital First in World to Offer Patients New FDA-Approved Device for Severely Calcified Arteries

Cardiac Catheterization Lab launches Diamondback 360 for use in United States


December 10, 2013
diamondback 360 mount sinai cath lab atherectomy
December 10, 2013 — Interventional cardiologists at Mount Sinai Hospital are the first in the world to use a newly U.S. Food and Drug Administration (FDA)-approved device for the treatment of severely calcified coronary arteries before the placement of a cardiac stent to open a blocked artery. 
The device being used in the Cardiac Catheterization Laboratory at Mount Sinai Hospital is Cardiovascular Systems Inc.’s Diamondback 360 Coronary Orbital Atherectomy System. It’s spinning electrically powered 1.25 mm diamond-coated crown is located on a thin cardiac catheterization guidewire and works within seconds to reduce the amount of hard calcium buildup in a coronary artery. The small calcium particles sanded from the artery’s wall are then naturally discarded from the heart and the body.
It is the first new coronary atherectomy system in more than two decades.
“We are excited that we are the first in the world to offer this innovation to our patients,” said Samin Sharma, M.D., director of clinical and interventional cardiology, Mount Sinai Hospital, and the Zena and Michael A. Wiener Professor of Medicine, Icahn School of Medicine at Mount Sinai. “This newly approved technology will allow us to significantly reduce our patients’ heart blockage percentage for more successful cardiac stent placement. Also, we hope its use will facilitate improved outcomes for these patients with severely calcified blockages who are traditionally more challenging to treat.”
Approximately 25 percent of patients with coronary artery disease (CAD) in need of a percutaneous coronary intervention (PCI) to treat a heart blockage have severe levels of arterial calcium lining their arteries. However, until now there have been limited treatment options to remove it. Increased arterial calcium can lead PCI patients to experience an increased risk of poor outcomes, major adverse cardiac events (MACE), or increased mortality.
“Previous clinical trial results (ORBIT II) testing the Diamondback system have shown it to be safe and effective in treating severely calcified lesions,” said Sharma. “Also, trial results showed most patients to be free from MACE following the procedure.”
Sharma is the national principal investigator of the MACE study for the newly FDA approved device. The study will prospectively evaluate the economic outcomes of treating varying degrees of calcified blockages in the coronary arteries.
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